Violence Against Health Care Workers in Fragile Settings

Workplace Violence Clinical Trial

— VIA-H  

Official title:

Violence Against Health Care Workers: Understanding Context Through Citizen Science and Measuring a De-escalation Training Intervention Effectiveness in Eastern Democratic Republic of Congo and Iraq

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419687
• Other study ID #: 70198
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: Sonja Merten, MD MPH PhD
• Phone: +41 61 284 83 87
• Email: sonja.merten[@]swisstph.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general objective of the project is to assess whether a violence de-escalating training for health professionals and of a publicly displayed Code of Conduct (a set of rules developed through a citizen science and co-design approach) for both health professionals and clients at the level of the health facility, can reduce the incidence and severity of episodes of violence, and to identify the most cost-effective way to implement these interventions in rural Democratic Republic of Congo (DRC) and in the mega city of Baghdad, Iraq.

Description:

The study will adopt a stepped-wedge cluster-randomized intervention trial (SW-CRT) design to assess the two intervention components, a violence de-escalating training and the implementation of the code of conduct co-developed during the formative qualitative phase. The study will adopt a closed cohort with repeated measurements on the same participants (nurses in DRC and junior doctors in Baghdad) and will involve the unidirectional transition of each enrolled cluster (health facilities in DRC and secondary hospitals in Baghdad) from the control (no intervention) to the intervention sequence in a randomized sequential manner according to a predefined roll out process.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 798
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HCWs from selected participating health facilities in DRC, junior doctors during their first year resident and permanent health care staff from participating secondary hospitals in Iraq
• HCWs and junior medical doctors and permanent health care staff must have been employed/ or worked as HCW/ medical doctors or as permanent health care staff for at least 6 months
• All above participants must have completed the written informed consent

Exclusion Criteria:

• Age <18 years; cognitive impairment

Related Conditions & MeSH terms

• Workplace Violence

Intervention

Behavioral:
• Training in de-escalating violence
Individual educational component through a de-escalating violence training for health care workers (verbal and non-verbal de-escalating techniques) Refreshment training in the form of collaborative learning
• Code of conduct delivered via a warning board
A publicly displayed code of conduct (a co-designed set of rules) for both HCWs and clients, delivered via a warning board at the level of the health facilities and secondary hospitals

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Catholic University of Bukavu, School of Public Health	Bukavu
Iraq	Al-Mustansiriya University	Baghdad

Sponsors (4)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Al-Mustansiriyah University, Catholic University of Bukavu, Democratic Republic of Congo, International Committee of the Red Cross (ICRC)

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Iraq, 

References & Publications (3)

Elrha, International Committee of the Red Cross (ICRC), RAND Europe. Researching Violence Against Health Care: Gaps and Priorities. 2020

Geoffrion S, Hills DJ, Ross HM, Pich J, Hill AT, Dalsbo TK, Riahi S, Martinez-Jarreta B, Guay S. Education and training for preventing and minimizing workplace aggression directed toward healthcare workers. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD011860. doi: 10.1002/14651858.CD011860.pub2. — View Citation

Leach, Brandi, Emily Ryen Gloinson, Alex Sutherland, and Michael Whitmore, Reviewing the Evidence Base for De-escalation Training: A Rapid Evidence Assessment. Santa Monica, CA: RAND Corporation, 2019.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of self-reported non-physical aggression	Number of self-reported non-physical aggression (verbal abuse, threats, ironic language, provocative or aggressive body language etc.) during the fulfillment of a professional activity in the last 6 months	6 months
Primary	Incidence and severity of self-reported physical aggression	Number of self-reported physical aggression during the fulfillment of a professional activity in the last 6 months	6 months
Secondary	Level of confidence in coping with patient aggression	Instrument "Clinicians confidence in coping with patient aggression (CCPAI) (Thackreys, 1987)"	0, 6, 12, 18 months
Secondary	Level of post-traumatic stress disorders (PTSD) among HCWs	Instrument "Post-traumatic stress disorder PTSD Checklist for DSM-5 (PCL-5)) (Weathers, F.W. et al. 2013)"	0, 6, 12, 18 months
Secondary	Level of burnout among HCWs	Instrument "Level of burnout" (Malach 2005), burnout measure short version (BMS). The ten-item version of the BMS are evaluated on 7-point frequency scales, with a score of 4 or above indicating burnout.	0, 6, 12, 18 months
Secondary	Psychological empathy among HCWs	Instrument "Jefferson scale of physician empathy (Hojat M et al. 2007)"	0, 6, 12, 18 months
Secondary	Absenteeism	Number of sick leave spells taken by the HCWs during the study period	0, 6, 12, 18 months
Secondary	Intent to leave among HCWs	The shortened, six-item version of the turnover intention scale (TIS-6) (Bothma & Roodt 2013), will be used to assess turnover intentions and as well as to predict actual turnover among HCWs. The TIS-6 scale is scored on a five-point Likert-type scale with scores ranging from 1 (never) to 5 ( always). A high score indicates stronger turnover intention.	0, 6, 12, 18 months
Secondary	Economic cost of the intervention	Two types of costs will be considered: 1) direct costs of the intervention (e.g training costs, space or rent costs, costs to develop the code of conduct) and 2) direct costs due to health system disruption (e.g. health care services foregone or postponed, material etc.), cost incurred by the HCWs as a consequence of violent episodes including direct medical costs (e.g. hospital stay cost, consultation costs, laboratory costs), non-medical costs (e.g. transportation, meals etc.), and indirect costs (e.g. absenteeism, presenteeism).	18 months
Secondary	Productivity loss (presenteeism)	Work Limitation questionnaire (WLQ) (Lerner D. et al. 2002). The WLQ consists of eight items investigating four domains (time management, physical tasks, mental-interpersonal tasks, and output tasks), which are calculated into scores ranging from 0 (no limitations) to 100 (highest limitations).	18 months
Secondary	Health care workers health-related quality of life	European Quality of Life-5 Dimensions (EuroQol EQ-5D-5L) (Devlin NJ et al. 2017). The EQ-5D-5L questionnaire is self-assessed and it measures health outcomes on five dimensions (mobility, self-care, daily activities, pain/discomfort, and depression/anxiety) with five levels ranging from none to major complaints. Scores range from 0 (death) to 1 (full health).	0, 6, 12, 18 months